Clinical study to Evaluate the Coldplay CryoBalloonTM Full and Swipe Ablation Systems for the Ablation of Human Esophageal Epithelium in Patients Undergoing Esophagectomy
Recruiting
- Conditions
- Barrett's esophaguscryoablation
- Registration Number
- NL-OMON29603
- Lead Sponsor
- C2 Therapeutics
- Brief Summary
Schölvinck DW, Künzli HT, Kestens C, et al. Treatment of Barrett ’ s esophagus with a novel focal cryoablation device : a safety and feasibility study. Endoscopy 2015.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 5
Inclusion Criteria
Patients must meet ALL of the following criteria to be eligible for participation in the study:
1.A minimum of two (2) areas of non-ulcerated columnar-lined esophagus or squamous-lined tissue suitable for ablation. Each ablation zone should be at least 1cm from the tumor and a minimum of 3cm in length. Sequential ablation zones must be a minimum of 1cm apart.
Exclusion Criteria
Patients must be excluded if ANY of the following criteria are met:
1.Patient refuses or is unable to provide written informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety and treatment effect of the CryoBalloonTM Ablation Systems. Safety will be evaluated by the incidence of serious, CryoBalloonTM Ablation System-related adverse events. Treatment effect of the CryoBalloonTM Ablation Systems will be evaluated by depth and uniformity of ablation effect in the esophagus. An esophagectomy will be performed immediately following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed.
- Secondary Outcome Measures
Name Time Method The secondary outcome is device performance: ease of deployment, procedure time, endoscope compatibility, and device malfunction.